In both types of leukaemia, some of the DNA (genetic material) has become rearranged to form an abnormal chromosome, called the Philadelphia chromosome.

ICLUSIG belongs to a group of medicines called tyrosine kinase inhibitors. In patients with CML and Ph+ ALL, changes in the DNA trigger a signal that tells the body to produce abnormal white blood cells. ICLUSIG blocks this signal, thereby stopping the production of these cells.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

This medicine is only available with a prescription from a doctor experienced with leukaemia treatment.

There is no evidence that this medicine is addictive.

Before You Take ICLUSIG

When you must not take it

Do not take this medicine if you have an allergy to:

ponatinib

any of the other ingredients of this medicine, listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue or other parts of the body

rash, itching or hives on the skin.

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

a severe side effect occurs, not affecting the blood:- pancreas inflammation- increased levels of the serum protein lipase or amylase

you develop heart or blood vessel problems.

ICLUSIG use may be resumed at the same, or at a reduced dose, after the event is resolved or controlled.

Your doctor may reduce your dose if your condition has responded well to ICLUSIG.

Your doctor may recommend you discontinue ICLUSIG if your condition has not responded to the treatment at all.

How to take it

Swallow the tablets whole, with a glass of water. The tablets can be taken with or without food. Do not crush or dissolve the tablets.

How long to take it

Take your medicine at about the same time each day.

Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

Make sure you take ICLUSIG daily for as long as it is prescribed. This is a long-term treatment.

If you forget to take it

If it is less than 12 hours before your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for a forgotten dose.

Take your next dose at your regular time.

If you are not sure what to do, ask your doctor or pharmacist.

Do not stop taking ICLUSIG without your doctor’s permission.

If you take too much (overdose)

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much ICLUSIG. Do this even if there are no signs of discomfort or poisoning.

You may need urgent medical attention.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

While You Are Taking ICLUSIG

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are taking ICLUSIG.

Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.

If you become pregnant while taking this medicine, tell your doctor immediately.

Things you must not do

Do not stop taking your medicine or lower the dosage without checking with your doctor.

Do not take ICLUSIG to treat any other complaints unless your doctor tells you to.

Do not give this medicine to anyone else, even if they have the same condition as you.

If you experience side effects that impair your vision or balance, your ability to drive a car or operate machinery could be impaired.

Side Effects

All medicines may have some unwanted side effects. Sometimes they are serious, most of the time they are not. Your doctor has weighed the risks of using this medicine against the benefits they expect it will have for you.

Do not be alarmed by the following lists of side effects.

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking ICLUSIG.

If you are over 65 years of age you may have an increased chance of getting side effects.

You may need medical attention if you get some of the side effects.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following side effects and they worry you:

nausea, vomiting, constipation, diarrhoea

abdominal distension, discomfort, indigestion, pain

stomach acid reflux

rash, dry skin, itching, peeling of the skin, skin pain

inflammation of hair follicles, hair loss

fatigue, sleeplessness, weakness

muscle spasms and pain, muscle weakness

hot flush/flushing, night sweats, increased sweating

decreased appetite, weight loss

dehydration

dry mouth, inflammation in the mouth

pins and needles, tingling or burning sensation in feet, legs, hands or arms

inability to develop or maintain an erection.

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you get any of the following side effects:

This leaflet was prepared by ARIAD Pharmaceuticals (Australia) Pty Ltd

Last revised: June 2016

CMI provided by MIMS Australia, May 2018

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